Benign Prostatic Hyperplasia
Conditions
Keywords
benign prostatic hyperplasia, alpha blocker
Brief summary
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.
Detailed description
This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance. All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)
Interventions
DRUGSilodosin
8 mg daily
Sponsors
Watson Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010.
Exclusion criteria
* Medical conditions that would confound the efficacy evaluation. * Medical conditions in which it would be unsafe to use an alpha-blocker. * The use of concomitant drugs that would confound the efficacy evaluation. * The use of concomitant drugs that would be unsafe with this alpha-blocker.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 9 months | All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) | 9 months | The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 8 mg Silodosin Per Day With Food | 661 |
| Total | 661 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 93 |
| Overall Study | Lack of Efficacy | 58 |
| Overall Study | Lost to Follow-up | 21 |
| Overall Study | Other | 14 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Withdrawal by Subject | 33 |
Baseline characteristics
| Characteristic | 8 mg Silodosin Per Day With Food |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 305 Participants |
| Age, Categorical Between 18 and 65 years | 356 Participants |
| Age Continuous | 65.0 years STANDARD_DEVIATION 7.79 |
| Region of Enrollment United States | 661 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 661 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 138 / 661 |
| serious Total, serious adverse events | 29 / 661 |
Outcome results
Primary
Adverse Events
All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.
Time frame: 9 months
Population: Safety population was analyzed. This population is defined as all enrolled patients who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 8 mg Silodosin Per Day With Food | Adverse Events | Patients with at least 1 adverse event | 431 participants |
| 8 mg Silodosin Per Day With Food | Adverse Events | Patients with drug related adverse event | 188 participants |
| 8 mg Silodosin Per Day With Food | Adverse Events | Patients with a serious adverse events | 29 participants |
| 8 mg Silodosin Per Day With Food | Adverse Events | Patients with a drug related serious adverse event | 0 participants |
| 8 mg Silodosin Per Day With Food | Adverse Events | Patients discontinued due to an adverse event | 86 participants |
| 8 mg Silodosin Per Day With Food | Adverse Events | Discontinued for drug related adverse event | 54 participants |
Secondary
International Prostate Symptom Score (IPSS)
The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms.
Time frame: 9 months